Wednesday, July 8, 2026

Drug profile · INN

methylphenidate hydrochloride

methylphenidate hydrochloride (TUZULBY) is a dopamine transporter inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Nervous system (N06) N06BA04
US status approved
Patents linked 0
Pipeline programs 3
News articles 0
Drug details — methylphenidate hydrochloride
US status
approved
Class
Nervous system (N06)
Route
ORAL
Patents
0
Programs
3
Data quality
0.89

Quick answer

methylphenidate hydrochloride (TUZULBY) is a dopamine transporter inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN methylphenidate hydrochloride
Brand TUZULBY
Mechanism Dopamine transporter inhibitor
Target Sodium-dependent dopamine transporter
Therapeutic class Nervous system (N06)
Route ORAL
Formulation TABLET, EXTENDED RELEASE
ATC code N06BA04

Mechanism of action

Dopamine transporter inhibitor

Primary target: Sodium-dependent dopamine transporter

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. HLD200 methylphenidate hydrochloride capsules Phase 3 · COLLEGIUM PHARMACEUTICAL · Attention Deficit Hyperactivity Disorder
  2. Dexmethylphenidate Hydrochloride Phase 1 · Teva Pharma · Healthy
  3. DR240305 Approved · Tour Hekla · Attention Deficit Disorder with or without Hyperactivity (AD

Related & competitor drugs

  1. amphetamine adipate Dopamine transporter releasing agent
  2. amphetamine aspartate Norepinephrine transporter releasing agent
  3. amphetamine sulfate Norepinephrine transporter releasing agent
  4. aripiprazole Nervous system (N05)
  5. armodafinil Dopamine transporter inhibitor
  6. brexpiprazole Nervous system (N05)

Frequently asked questions

What is methylphenidate hydrochloride?

methylphenidate hydrochloride (TUZULBY) is a dopamine transporter inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for methylphenidate hydrochloride?

TUZULBY is a marketed brand name for methylphenidate hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of methylphenidate hydrochloride?

methylphenidate hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.